Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073192
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2016 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/13/2012 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

06/27/2007 SUPPL-22 Labeling

Label is not available on this site.

08/30/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/09/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/29/1995 SUPPL-10 Labeling

Label is not available on this site.

03/02/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/13/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LOPERAMIDE HYDROCHLORIDE

CAPSULE;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;ORAL Prescription No AB 072741 MYLAN
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG CAPSULE;ORAL Prescription No AB 073192 TEVA

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